MINUTEX D-DIMER LATEX TEST— 510(k) K920668

Substantially Equivalent

Biopool AB

FDA 510(k) clearance K920668 for MINUTEX D-DIMER LATEX TEST, Substantially Equivalent on 1992-10-16. Applicant: Biopool AB. Device class: 2.

Clearance details

Applicant: Biopool AB
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1992-02-13
Decision date: 1992-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, L7l 6b8, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.